Clinical Trial: Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase II, Randomized, Double-Blind, Parallel Group, Acyclovir-Controlled Study to Evaluate ZEP-3 Ointment for the Treatment of Cold Sores (Herpes L
Brief Summary: This is a phase II, prospective, randomized, double-blind, parallel group, acyclovir-controlled clinical study to evaluate the safety, tolerability and preliminary therapeutic efficacy of ZEP-3 ointment 1.0% for the treatment of cold sores (Herpes labialis), following five consecutive treatment days with five times daily topical administration.
Detailed Summary:
The primary endpoint of this study are:
- "Time to healing" - Clinician-assessed duration in days of herpes labialis episode.
- Patient-assessed duration and intensity of pain by Visual Analog Scale (VAS).
- Safety and tolerability following five consecutive treatment days with five times daily topical administration.
The secondary endpoints of this study are:
- Proportion of subjects with non - ulcerative herpes lesion.
- Time for herpes labialis recurrences
Subject safety will be assessed following treatment by ZEP-3 ointment 1.0% or acyclovir cream 5% treatment, using measurements of the following variables:
- Physical examination,
- Vital Signs (HR, BP, Body temperature),
- Adverse events recording and
- Concomitant medications
Sponsor: Shulov Innovate for Science Ltd. 2012
Current Primary Outcome: Clinician-assessed "Time to healing" [ Time Frame: Up to 14 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Time for Herpes labialis recurrences [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Shulov Innovate for Science Ltd. 2012
Dates:
Date Received: June 24, 2015
Date Started: September 2015
Date Completion: October 2016
Last Updated: January 5, 2016
Last Verified: January 2016
